NMIBC
Conditions
Brief summary
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).
Interventions
DRUGSHR-1501 for Injection
SHR-1501 for injection.
DRUGBCG for Injection
Bacillus calmette guerin (BCG) for injection.
DRUGEpirubicin Hydrochloride for Injection
Epirubicin hydrochloride for injection.
DRUGPirarubicin Hydrochloride for Injection
Pirarubicin hydrochloride for injection.
DRUGGemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
DRUGHydroxycamptothecin for Injection
Hydroxycamptothecin for injection.
DRUGMitomycin for Injection
Mitomycin for injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized, positive controlled, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 18 years, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; 3. Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive; 4. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue; 5. Not suitable for or unwilling to undergo radical cystectomy; 6. Sufficient hematology and organ function.
Exclusion criteria
1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+); 2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization; 3. Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC; 4. Those who have previously received immunostimulant therapy; 5. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration; 6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR) | Up to approximately 5 years. | Disease free survival is defined as the time from randomization to date of DFS event assessed by BICR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) assessed by investigator | Up to approximately 5 years. | Disease-free survival (DFS) is defined as the time from randomization to date of DFS event assessed by investigator. |
| Overall Survival (OS) | Up to approximately 5 years. | Overall Survival (OS) is defined as the time from randomization to date of death from any cause. |
| Number of adverse events (AEs) as assessed by CTCAE v6.0. | Up to approximately 5 years. | — |
| Number of serious adverse events (SAEs) as assessed by CTCAE v6.0. | Up to approximately 5 years. | — |
Countries
China
Contacts
CONTACTWenliang Wang
CONTACTQi Zhang
Outcome results
None listed